FDA-Drug2026-07-29Class IIPROCESSING DEFECT
Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
Nationwide distribution
Fresenius Kabi Xylocaine injection recalled for particulate contamination
Hair was found in vials of Xylocaine (lidocaine HCl Injection, USP) 1% supplied by Fresenius Kabi. The affected product is a multiple-dose vial medication used for local anesthesia. This contamination could pose a risk if the injection is administered without detection.
- Check your facility's inventory for Lot #6130235 with expiration date 02/2027 (NDC Vial: 63323-485-01).
- Visually inspect vials for any particulate matter before use.
- Do not use affected vials; contact your supplier or Fresenius Kabi for replacement or credit.
- Report any adverse events or injuries to the FDA MedWatch program.
Hazard
Presence of Particulate Matter: Hair was found in products
Sold states
Nationwide within in the USA
Affected count
93,250 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0728-2026More Fresenius Kabi USA, LLC recalls
- FDA-Drug2026-07-29Fresenius Kabi Naropin injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
- FDA-Drug2026-06-17Fresenius Kabi epinephrine injection recalled for failed impurity specifications
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